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Request a proposal

How the fee is set

Annual fee by device class, from €800 for class I to €2,000 for class III. No setup fee. Changing representative costs €150. Rates are fixed for three years from signature.

What happens next

We check your device list and the Annex VIII class, send the proposal with a draft mandate under Article 11(3), and after signature link your EUDAMED registration to our authorised representative SRN TR-AR-000057550.

Our offices

İstanbul

Zuhal Cad. Ritim İstanbul B Blok No: 44,

Maltepe - TÜRKİYE
regulatory@medexeurep.com

+90 546 104 8101

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Gdańsk
Aleja Grunwaldzka 347

80-309

Gdańsk - POLAND
info@medexeurep.com

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Tell us about your devices. Within one business day you receive a fixed-price written proposal and a draft Article 11 mandate.

REGISTER IN EUDAMED

Send your device list for a written quote

Highest device class
Services you need

Share a folder link with your device list, DoC, certificates, labels and IFU, or email them to regulatory@medexeurep.com.

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